colestipol hydrochloride

Generic: colestipol hydrochloride

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colestipol hydrochloride
Generic Name colestipol hydrochloride
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colestipol hydrochloride 1 g/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-284
Product ID 50742-284_f784d09d-69b6-4e7b-a1eb-8b7e839cd4db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217462
Listing Expiration 2026-12-31
Marketing Start 2024-12-03

Pharmacologic Class

Classes
bile acid sequestrant [epc] bile-acid binding activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742284
Hyphenated Format 50742-284

Supplemental Identifiers

RxCUI
1048445
UPC
0350742284122
UNII
X7D10K905G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name colestipol hydrochloride (source: ndc)
Generic Name colestipol hydrochloride (source: ndc)
Application Number ANDA217462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (50742-284-12)
source: ndc

Packages (1)

50742-284-12 120 TABLET, FILM COATED in 1 BOTTLE (50742-284-12)

Ingredients (1)

colestipol hydrochloride (1 g/1)

Linked Drug Pages (1)

Colestipol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f784d09d-69b6-4e7b-a1eb-8b7e839cd4db", "openfda": {"upc": ["0350742284122"], "unii": ["X7D10K905G"], "rxcui": ["1048445"], "spl_set_id": ["3fa27483-8346-4145-81c0-5527204d7d68"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (50742-284-12)", "package_ndc": "50742-284-12", "marketing_start_date": "20241203"}], "brand_name": "Colestipol Hydrochloride", "product_id": "50742-284_f784d09d-69b6-4e7b-a1eb-8b7e839cd4db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "50742-284", "generic_name": "Colestipol Hydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colestipol Hydrochloride", "active_ingredients": [{"name": "COLESTIPOL HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA217462", "marketing_category": "ANDA", "marketing_start_date": "20241203", "listing_expiration_date": "20261231"}